Summary
It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation
Conditions
Pain, Postoperative
Recruitment Status
Completed
Detailed Description
This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery. The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants. The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.
Eligibility Criteria
Inclusion Criteria:
All patients will be admitted to the NICU, and having a post-menstrual age of >28 weeks. Participants will be divided into four groups according to the following criteria:
Group A
Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade
Group B
Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
Patients who are not anticipated to receive acute post-surgical neuromuscular blockade
Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair);
Group D No plan for surgery
Exclusion Criteria:
Confirmed or suspected clinical seizures
Metabolic abnormalities or inborn error of metabolism
Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes
Intervention
Intervention Type
Intervention Name
Device
Waveguard (TM) EEG cap
Device
Micro Movement Sensor
Device
Pico Movement Sensor
Device
QS Piezostimulator
Device
tactileTM sensory evaluator
Gender
All
Min Age
1 Hour
Max Age
6 Months
Download Date
September 15, 2022
Principal Investigator
Laura Cornelissen PhD
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: